A Study of LY2928057 in Hemodialysis Participants

NCT01991483 | Completed Phase 1 Results

• 2 other identifiers: 15268I5M-MC-FABC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant discontinues or reduces treatment to stimulate red blood cells. This study will last up to 26 weeks for each participant.

Conditions

Renal Insufficiency, Chronic; Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (2)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

  Baseline to Study Completion (up to Day 137)

• Change From Baseline in Hemoglobin at 6 Week Endpoint

  Baseline, Day 42

Secondary Outcomes (14)

• Pharmacodynamics (PD): Maximum Change in Hemoglobin

  Baseline through 6 Weeks

• Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline

  Baseline, 6 weeks

• Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat)

  Baseline through 6 weeks

• Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr)

  Baseline through 6 weeks

• Pharmacodynamics (PD): Maximum Change in Reticulocyte Count

  Baseline through 6 weeks

Study Arms (4)

LY2928057 (No ESA)

EXPERIMENTAL

Multiple doses of LY2928057 administered intravenously (IV) either once every 2 weeks (Q2W) or once per week (QW) for 6 weeks. Participants discontinued their personal physician-prescribed erythropoiesis stimulating agent (ESA) before treatment.

Drug: LY2928057

LY2928057 (Reduced ESA)

EXPERIMENTAL

Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.

Drug: LY2928057

Placebo (No ESA)

PLACEBO COMPARATOR

Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment.

Drug: Placebo

Placebo (Reduced ESA)

PLACEBO COMPARATOR

Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.

Drug: Placebo

Interventions

LY2928057 DRUG

Administered intravenously

LY2928057 (No ESA); LY2928057 (Reduced ESA)

Placebo DRUG

Administered intravenously

Placebo (No ESA); Placebo (Reduced ESA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants having end-stage renal disease (ESRD), have received an erythropoiesis stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening (that is, an approximate Kt/V greater than 1.1 (K equals dialyzer clearance of urea, t equals dialysis duration time, V equals volume of distribution of urea, which is approximately equal to the participant's total body water) based on the clinical judgment of participant's nephrologist and investigator and who are willing to stop (Parts A and B) or reduce (Part C) their stable ESA dose from the week of randomization until completion of the 6-week treatment period (unless rescue therapy is needed)
• Have a hemoglobin value (taken prior to dialysis if taken on a dialysis day) greater than or equal to 9.5 grams per deciLiter (g/dL) and less than or equal to 12.5 g/dL at screening
• Have a body mass index (BMI) of 18.5 to 45 kilograms per square meter (kg/m\^2) inclusive at screening
• Have a transferrin saturation (TSat) greater than or equality to 15 percent and ferritin greater than 40 nanograms per milliliter (ng/mL) at screening

You may not qualify if:

• Any cause of anemia other than renal disease
• A history of hyporesponsiveness to ESA

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Davita Clinical Research, DN

Lakewood, Colorado, 80228, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

• Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4.

  PMID: 30677788 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 7, 2019
• Results First Posted: February 7, 2019

Record last verified: 2019-03

Locations

US (4)